TOPICAL ANESTHETIC  RASPBERRY- benzocaine gel 
Patterson Dental Supply Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Patterson Topical Anesthetic Raspberry Flavor

INGREDIENTS

Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40, FD&C Blue #1 and FD&C Red #28.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

CAUTION

Federal law prohibits dispensing without a prescription.

WARNING

Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.

Store at controlled room temperature 59-86°F (15-30°C).

MADE IN U.S.A.
Distributed by:
PATTERSON DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

PATTERSON
DENTAL

NDC#50227-2113-1

Topical Anesthetic

Raspberry Flavor Gel

Contains 20% Benzocaine

For Professional Use Only

Net Contents 1 fl oz (29.6 mL)

Reorder Number
090-0043

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label
TOPICAL ANESTHETIC   RASPBERRY
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50227-2113
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Water (UNII: 059QF0KO0R)  
FD&C Red no. 40 (UNII: WZB9127XOA)  
FD&C Blue no. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorPURPLE (Purply-Red) Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-2113-129.6 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/19/1963
Labeler - Patterson Dental Supply Inc (171843584)

Revised: 4/2012
Document Id: b56a0462-a028-4d4d-8a21-036ac1ac53bc
Set id: 2d15c773-d789-4872-be8e-2c0ccca5e0e4
Version: 1
Effective Time: 20120409
 
Patterson Dental Supply Inc